Sep 3
Pros and Cons of Virtual Audits
Over the last year and a half, so many things have changed. We’ve had to adopt new practices to ensure the safety and wellbeing of not only ourselves, but also our friends, family and the general public.
Aside from working from home, one big change for medical device manufacturers is in auditing. We’ve completely shifted from onsite audits to virtual audits, with many certification bodies offering virtual audits as an option moving forward even with the economy re-opening.
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This blog provides an overview of Medical Device Manufacturing Cleanrooms and draws upon our experience validating our Class 7 Cleanroom.
Keeping current with Health Canada’s medical device regulatory developments
Symbols are a universal language. When looking at smiley and sad faced emojis anyone from around the world can differentiate the meaning between the two. That is the power of symbols.
Medical Device Drop Test Per IEC 60601-1 Ed 3.2 Clause 15.3.4
Physical testing is an essential tool for product development, particularly when developing a novel medical device. When well designed, a physical test can accurately represent phenomena that are difficult to model, and physical tests can often be constructed quickly with a minimum of custom components.
Ensuring new hires feel connected to the team and engaged in their position is critical. So much has changed since moving to remote work, including the onboarding process. Don’t be fooled; the initial weeks or months aren’t just when an organization assesses their new hire, it’s also for the new employee to determine if they will be able to thrive within their new team.
